Artificial heart assembly and heart assist device

ABSTRACT

An artificial heart assembly comprising a pair of ventricles, a pair of atria or inflow means, a pair of sinus or outflow means for pumped blood, and fluid pumps to drive the ventricles. In a modification, a single ventricle is used as a ventricular assist device. Each ventricle has a shell providing a ventricular cavity and at least one pumping chamber in the shell. The chamber has a flexible non-stretching wall and a rigid wall sealed to each other. The rigid wall has an aperture to permit entry of the pumping fluid into the chamber. A blood-compatible material covers all blood-exposed surfaces in the cavity.

United States Patent [1 1 Kahn et al.

[ Oct. 23, 1973 ARTIFICIAL HEART ASSEMBLY AND HEART ASSIST DEVICE [75]Inventors: Paul Kahn, San Francisco; Ronald C. Brown, Oakland, both ofCalif.

[73] Assignee: Cutter Laboratories, Inc., Berkeley,

Calif.

[22] Filed: Aug. 20, 1971 211 App]. No.: 173,396

Related U.S. Application Data [63] Continuation-in-part of Ser. No.72,628, Sept. 16,

1970, abandoned.

[52] U.S. Cl. 3/1, 3/DIG. 2, 128/1 R, 128/DIG. 3 [51] Int. Cl. A61I 1/24['58] Field of Search.; 3/1, DIG. 2; 128/1 R, DIG. 3, 334 R, 334 C [56]References Cited UNITED STATES PATENTS 3,553,736 1/1971 Kantrowitz etal. 3/DIG. 2 3,254,651 6/1966 Collito 128/334 C FOREIGN PATENTS ORAPPLICATIONS 1,503,906 10/1967 France 3/DIG. 2

OTHER PUBLICATIONS Orthotopic Cardiac Prosthesis: PreliminaryExperiments in Animals with Biventricular Artificial Heart by M. E.DeBakey et al. Cardiovascular Research Center Bulletin Vol. VII No. 4,April-June 1969, pages 127-133 and 136-138.

A Pseudoendocardium for Implantable Blood Pumps by D. Liotta et a1.Trans. Amer. Soc. Artif. Fnt. Organs, Vol. XII, 1966, pages 129-134.

A Prosthetic Heart with Hemispherical ventricles designed for LowHemolytic Action by C. Kwan Gett et al.. Trans. Amer. Soc. Artif. Int.Organs, Vol. XVI, Apr. 1970, pages 409-415.

A Time and Volume Controlled Extracorporeal Pump by J. R. Hinglais etal., Trans. Amer. Soc. Artif. Int. Organs, Vol. XIII, 1967, pages317-321.

Primary ExaminerRichard A. Gaudet Assistant Examiner-Ronald L. FrinksAttorney-Bertram Bradley et al.

[57] ABSTRACT An artificial heart assembly comprising a pair ofventricles, a pair of atria or inflow means, a pair of sinus or outflowmeans for pumped blood, and fluid pumps to drive the ventricles. In amodification, a single ventricle is used as a ventricular assist device.Each ventricle has a shell providing a ventricular cavity and at leastone pumping chamber in the shell. The chamber has a flexiblenon-stretching wall and a rigid wall sealed to each other. The rigidwall has an aperture to permit entry ofthe pumping fluid into thechamber. A blood-compatible material covers all blood-exposed surfacesin the cavity.

27 Claims, 9 Drawing Figures PATENTED 001 23 i973 SHEET 10; 5V

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I SHEETSDF 5 INVENTORS PAU L K A H N N 20 M1 18 BY RONALD c. BROW gATTORNEYS ARTIFIC-IALI-IEART ASSEMBLY AND HEART ASSIST DEVICE CROSSREFERENCE TO RELATED APPLICATION BACKGROUND OF THE INVENTION Thisinvention relates to an artificial heart assembly that is implantable ina human being or an animal for functioning similarly to the naturalheart, and also relates to a heart assist device for supporting anatural heart. Either assembly can function over an extended period oftime, providing controllable pressure, volume, and rate control. Bothassemblies are bloodcompatible and require little, if any,anticoagulation. Implantation is relatively easy and convenient.

Devices are known which use pneumatic or hydraulic pressure as a motiveforce to activate an artificial heart or heart assist. The singleventricle of the assist or each of the two ventricles used in a totalprosthesis usually has comprised a double walled chamber with an innerbladder representing the ventricular cavity, pressure being applied inthe outer chamber. The outer wall, whether rigid or flexible, has had atubulation for transmission of the gas or fluid medium, but there hasbeen no specific control of the pump volume, and the expansion andelasticity of the pneumatic or hydraulic chamber has required excessivepumping and relief time, due to expansion of the outer chamber andcompressibility of the medium. The atrial connection chambers haveusually been attached to the ventricles, and the ventricles have beenconnected in a way that has tended to cause difficulties in the surgicalprocedure for installation of the artificial heart.

The above difficulties are overcome by the device of the presentinvention, and other advantages will become apparent from thedescription which followsFor instance, the ventricle of the presentinvention provides a precise and predetermined pump volume; the pumpingchamber walls are flexible and non-elastic and as a result provide amore constant and uniform supply of blood under controllable pressureand at a controlled rate. The atria and sinuses as part of theprostheses are detachable from the ventricles so that at the time ofsurgery, attachment of these parts to theatrial remnants and arteriesafter removal of the heart or to the apex of the left ventricle (in thecase of the assist) is more readily accomplished. The blood-contactingsurfaces of this new device are blood-compatible with minimal embolicrisk.

BRIEF SUMMARY OF THE INVENTION The present invention provides anartificial heart assembly or a heartassist device which can be implantedin an animal or human body and which provides a constant and uniformpulsing flow of blood, with minimal risks of coagulation, embolism orinfection, and with optimal ease of installation and use.

The invention provides a ventricle containing one or more pumpingchambers. A means for introducing a fluid, either gas or liquid, isprovided for each pumping chamber. A prosthetic heart assembly includesone or two such ventricles while a heart assist uses a single ventricle.The pumping fluid is kept separated from the blood, and there is meansfor connecting the blood outlet from each ventricle to one of the bodysarterial systems. An atrium connects the ventricle to the patientsvenous system in the total heart device. In the heart assist, a specialconnection joins the patients left ventricle to the assist device. Inboth devices, there are inflow and outflow valves located in the inflowand outflow means, respectively.

7 Each pumping chamber comprises a rigid outer wall anda flexible,nonstretching diaphragm wall, the two walls being secured together at oradjacent their edges, as by sutures or by cement or by compressionseal,to define a generally ovoid bladder when inflated. When deflated, theflexible membrane lies against the rigid wall while the central space orblood-flow chamber of the ventricle, in which the pumping space isdisposed, fills with the blood to be pumped. The walls of the blood-flowchamber and any other surfaces of the device or assembly which areexposed to blood are provided with a blood-compatible covering,advantageously Dacron velour. The rigid wall is made of aphysiologically compatible material such as stiffened silicone rubber,resin-impregnated glass-fiber cloth, or

a suitable plastic or metal.

The present invention provides separate impervious non-stretchingpumping chambers of the exact size desired. While a single chamber maybe used, two pumping chambers are preferably used for each ventricle, inorder to economize size and movement and to provide central flow'ofblood in the ventricle. One side of each chamber the outer side is maderigid to force expansion to take place only in the desired direction,which is inwardly. Fluid or gas passages are provided in this rigidshell so that the movable diaphragm is uncomplicated in form in theinterest of extending flexural fatigue life. The diaphragm membrane isnon-stretching and is impervious to liquid and gas, to providecontrolled pressure, volume, and position in the ventricle and toseparate the pumping fluid from the blood by separating the pumpingchamber from the blood-flow chamber. Prefabrication of the pumpingchambers enables their pretesting to assure freedom from leaks.

The pumping chambers are assembled into the ventricle, usually beingplaced at an angle to give the most economical use of space, and toprevent their touching opposing walls when fully expanded to minimizered cell trauma. This enables control of the volume and pressure. Whenmore than one expansion or pumping chamber is used in a singleventricle, the expansion or pumping chambers are preferablyinterconnected at the base or tip of the ventricle to a common gas orliquid conduit. A separate conduit is provided for each ventricle. Theventricle is preferably shaped to be round or oval laterally, toaccommodate the expansion or pumping chambers in the side wall or walls,and the inflow and outflow valves fit naturally into the spaces at thetop of the ventricle. The entire ventricle is lined with an imperviouslining, such as velour, especially Dacron velour, or otherblood-compatible material.

The atria and sinus, which may be part of the inflow and outflow means,may be fabricated separately, so that the ventricle may be attached tothem by suitable connectors which mate with connectors on top of theventricle. This attachment is done after the atria and sinus aresurgically attached to the patient or animal. This technique results ineasier surgical insertion and manipulation.

When a single ventricle is used as a heart assist device, the patientsown heart is left intact in this application. A suitable connector isplaced in the apex of the left ventricle to draw blood out of thepatients left ventricle into the artificial ventricle via a flexibleplastic tube such as a Dacron tube. The artificial ventricle or heartassist may be placed in the abdominal cavity, inferior to the diaphragmor it may be left outside the body. The artificial ventricle then pumpsblood through a suitable flexible tube into the descending aorta. Valvesare located at the top of the artificial ventricle. This device relievesthe load on a patients own heart for an indefinite period of timepermitting his own heart to recover sufficiently to resume its fullcapacity.

Other objects and advantages of the invention will appear from thefollowing description of some preferred embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a partially exploded view inside elevation of an artificial heart ventricle, embodying theprinciples of the invention, with a prosthetic valve and an atrium shownready for insertion and attachment. A detachable sinus and outflowprosthetic valve are shown connected. The attachment to a pump is brokenand is shown-partly diagrammatically.

FIG. 2 is a view in section, taken along the line 22 in FIG. 1, with thepumping chambers collapsed.

FIG. 3 is a view similar to FIG. 2 with the pumping chambers expanded toa maximum.

FIG. 4 is a view in section, taken along the line 4-4 in FIG. 1, withthe pumping chambers expanded as in FIG. 3.

FIG. 5 is a view in perspective of two of the ventricles of FIG. 1attached to each other to provide a complete heart prosthesis.

FIG. 6 is an exploded enlarged fragmentary view in section of a portionof the apparatus showing the connectors and a valve between the atriumand the ventricle.

FIG. 7 is a view similar to FIG. 6 with the parts assembled.

FIG. 8 is a fragmentary view partially in section of a heart assistdevice embodying the principles of the invention, completely connectedto the patients heart and descending aorta.

FIG. 9 is a view in section of an apex connector used with the heartassist device.

DESCRIPTION OF SOME PREFERRED EMBODIMENTS An entire totally artificialheart 10 (see FIG. 5) of this invention comprises two identicalartificial ventricles 11 and 12, two atria l3 and 14 serving as bloodinflow means into their respective ventricles 11 and 12, and two sinus15 and 16 serving as the outflow means for blood from the respectiveventricles 11 and 12.

Each of the two identical ventricles l1 and 12 has an air bleeder line17 (see FIG. 1) and gas or fluid lines 18 or 19 for the pumping fluid,leading to a pump 20 (FIG. 1). Between each atrium 13, 14 and itsventricle 11, 12 is an inflow or atrioventricular valve 21, locatedwhere a flanged connector 22 on the atrium 13 meets and mates with aflanged connector 23 on the ventricle 1 l. The atrium 13 has a wall 24at its other end for attachment to the patients residual atrial wallsafter removal of the recipient's heart. Between each ventricle 11, 12

and its sinus 15 or 16 is an outflow or sinuventricular valve 25 housedin similar flanged connectors 26 and 27. The sinus 15 and 16 also havetubulation 28 for connection to the patients aorta or pulmonary artery.The flanged connectors 22, 23 and 26, 27 greatly ease the technicalproblem of insertion of the prosthesis 10 at the time of surgery, sincethe atrium 13 and sinus 15 can be surgically installed individually,unencumbered by the ventricle 11. Connection of the ventricle 11 to itsatrium 13 and sinus 15 is simplified in that one merely plugs" the partstogether, securing the flanges to one another with sutures threaded intoholes provided in the flanges as described below. After the prostheticheart 10 is fully assembled, it is filled with blood, and any air isremoved via the bleeder line 17, which is then sealed. The gas or fluidline 18 (or 19) is brought out through the body wall 29 and connected toa suitable power source or pump 20 for continued operation of thedevice. Individual power sources are used for each ventricle 11, 12since the pressure requirements for the arterial and pulmonarycirculations are different.

The ventricle 11 shown in FIGS. 1-4 has an outer shell 30 made of rigidmaterial, preferably fiberglassreinforced epoxy resin, though it may bemade from other rigid plastics, or from metal, so long as these arebiologically compatible, or the shell 30 may be made so biologicallycompatible by covering or coating a rigid material with a compatiblematerial such as stiff silicone rubber. The shell 30 provides aventricular cavity 31, and, disposed within the cavity 31 is at leastone pumping chamber, preferably two pumping chambers 32 and 33 connectedto respective gas passages 34 and 35. The chambers 32 and 33 areseparated from the blood by twofluid impervious membranes 36 and 37,preferably made from silicone rubber impregnated Dacron fabric or othersuitable non-stretching, flexible material. The membranes 36 and 37 arepreferably wrapped around the edges and bonded to the back surfaces ofinner shells 38 and 39 respectively. These inner shells are preferablymade of material similar or identical to that of the outer shell 30.Openings 40 and 41 are provided in the inner shells 38 and 39 to enablefluid to enter the chambers 32 and 33.

The enclosed pumping chambers 32 and 33 are thus bounded partly by theinner shell 38 and 39 and partly by the fluid-impervious but flexiblediaphragms or membranes 36 and 37. The blood exposed surfaces of thediaphragms 36 and 37 and of the outer shell 30 are covered by a bloodcompatible material 42 such as Dacron velour, by impregnating one sideof the velour without filling the pile on the other side with a suitablemedical rubber impregnant and then adhesively attaching the velour 42 tothe diaphragms 36 and 37 and the shell 30. Also the tube 18 whichconnects the power source 20 to the gas passages 34 and 35, preferablyvia a Y-shaped connector 43, is preferably exteriorly coated with Dacronvelour 44.

The pressure chambers 32 and 33 are preferably placed so as to be on aslight angle to the vertical centerline of the ventricular cavity 31that is, they diverge from each other and from the blood flow chamber 45upwardly and outwardly from the lower end 46 of the shell 30 so thatwhen the chambers 32 and 33 are fully expanded, their flexible diaphragmwalls 36 and 37 do not touch each other, minimizing blood trauma. Thepumping chambers 32 and 33 may be placed in position and affixed to theinterior surface of the outer shell 30, for example, by cementing theinner shells 38 and 39 to the outer shell 30 with a medical rubbercement.

At the top of ventricle l l is a blood inlet area 47 and a blood outletarea 48. FIGS. 6 and 7 show the configurations of the connectors 22,23between the ventricle 11 and the atrium 13, and the connectors 26 and 27are substantially the same as the connectors 22 and 23. The

body 50 of the ventricular or male connector 23 can be an integral partof the ventricle shell 30 or can be made from another piece and bondedor welded to the shell 31}. An annular recess 51 with a shoulder 52 isprovided in the body 50 of the connector 23 in which the valve 21 isseated and is mechanically locked in position by press fit. The valve 21is preferably a Wada-Cutter tilting disc valve but may be any suitableprosthetic or tissue valve. The blood compatible lining 42 is continuedright up to the valve 21. The atrial or female connector 22 has a body53 with an annular receptacle 54 having a cylindrical wall 55 and ashoulder 56, against which end wall 57 of the body 50 abuts, the bodies50 and 53 nesting together tightly.

Against a shoulder 61 of the body 50, a flange 60 is mounted so that itcan be rotated relatively to the body 50, and the flange 60 mates with aflange 62 on the body 53, preferably fixed to the body 53. These flanges60 and 62 are made of rigid material suchas stainless steel or othersuitable material such as rigid plastic or fiberglass-reinforced epoxyresin. The flanges 6t) and 62 each have a spaced series of holes 63 and64 respectively, distributed around the peripheries of the flanges 6t)and 62 so that the two flanges 60 and 62 can be sutured together,thereby firmly securing the two connectors 22 and 23 together. Theflange 60 can be rotated about the vertical axis so as to align theholes 63 and 64. The generally cone-shaped atrium 13 is preferablyconstructed from silicone rubber sheet 65 (which may be reinforced withfabric) and along with a blood compatible lining 66, preferably Dacronvelour, is bonded to" the body 53 of the connector 22. The connectors 26and 27 between the sinus and'the ventricle'll are identical to theconnectors 22 and 23 except that the outflow valve 25 is. a flipped-overvalve 21 so as to function properly. t

In surgery the surgeon connects to the patient an ex- -'ternalheart-lung machine. to maintain thepatients circulation and oxygenation;while the operation is in progress. By one method, he takes out thepatients natural heart and puts in the first or lower atrium 13,suturing it to an atrial remnant. The second atrium 14 is then suturedto the other atrial remnant. The arterial graft tubing 28 attached tothe sinus 15 is sutured to the pulmonary artery, and the second sinus 16is attached to the aorta via additional arterial graft tubing 28. Theconnectors 23-and 27 of the ventricles 11 and 12 are then plugged intothe atrial and sinus connectors 22 and 26, securing them by suturesthrough the holes 63 and 64 in the connector flanges 60 and 62. Theventricles l l and 12 are then attached to each other by straps 67 ofsilicone impregnated Dacron cloth, which are bonded to each ventricleand are then sewn to each other.

In another embodiment, a single ventricle 11 can be the apex 72 of theheart 73 via a suitable apex connector 74.

This apex connector 74 (see also FIG. 9) is provided with an internalradial extension 75 for positioning the apex connector 74 flush with theinner surface of the heart 73. The apex connector 74 also has anotherradial extension, a sewing flange 76 for suturing the apex connector 74to the heart muscle.

As shown in FIG. 9, the apex connector 74 preferably has a thin metal orplastic tube 77 for stiffening the apex connector 74. The inner andouter surfaces of the tube 77 are covered with adhesive 78 such assilicone rubber, to bond to it an exterior sleeve 80 of blood compatiblematerial and an inner sleeve 81 of bloodcompatible material, bothsleeves preferably being Dacron velour. The radial extensions 75 and 76may have fillers 82 and 83, such as silicone rubber sheet, to providebulk. The sewing flange 76 may be attached to the body of the apexconnector 74 by suturing through holes 84 provided around the peripheryof a flange 85 that is part of the rigid tubing 77. A tubular extension86 is provided for attachment by suture to arterial graft tubing 87.

This tubing 87 is, in turn, sutured to a heart assist inflow adapter 88,which, like a heart assist outflow adapter 89, is constructedessentially from the same materials as the atrium l3 and sinus 15, i.e.,silicone rubber sheeting lined with blood compatible material,preferably Dacron velour. Built into the assist adapters 88 and 89 areconnectors 90 and 91 like the connector 22 of FIGS. 6 and 7 for easyattachment to the connectors 23 and 27 on the ventricle 11. As in thetotal heart 10, inflow and outflow valves are housed inside theconnectors 23 and 27 on top of the venricle ll. Arte rial-graft tubing92 is sewn onto the heart assist outflow adapter 89 and to the patientsdescending aorta 71. Both arterial graft tubings 87 and 92 are made offlexible, non-collapsing materials, for example, spirally wound metalwire covered with silicone with an interior bonded covering of Dacronvelour.

At the time of surgery a hole is punctured in the apex 72 of thepatients heart 73, and the apex connector 74 is inserted. The sewingflange 76 is sutured to the heart muscle. Holes 93 and 94 are cut in thepatients diaphragm 95, and the arterial graft tubes 87 and 92 areinserted through these holes 93 and 94. The tube 87 is sutured to theapex connector 74, and the tube 92 is sutured to the descending aorta71. The assist adapters 88 and 89 may be attached by suturing to thetubes 87 and 92 at this point, or they may have been sutured prior tosurgery. The connectors 23 and 27 of the ventricle 11 are then pluggedinto the connectors 90 and 91 of the adapters 88 and 89 and secured bysutures. The fluid pressure line 18 is brought out through the body wall29 as in FIG. 1 and is attached to the power source 20 as describedpreviously.

The above specific description and the drawings have been furnished forillustrative purposes only, and variations and modification can be madewithout departing from the spirit and scope of the invention.

What is claimed is:

1. An improved artificial ventricle including in combination:

a generally rigid ventricle shell means providing a ventricular cavityand having inlet means and outlet means for blood, said verticle shellmeans comprising an outer shell and an inper shell,

pumping means providing at least two pumping chambers within said cavityand comprising a diaphragm for each pumping chamber secured between saidinner and outer shells and dividing the pumping chamber from ablood-flow chamber in said cavity, each said diaphragm being a flexible,non-stretching, impervious membrane, said inner shell having aperturemeans enabling entrance of pumping fluid into said pumping chambers,said inner shell being sealed at its back side to each said diaphragmand to said outer shell.

blood-compatible material covering all bloodexposed surfaces of saidventricle shell and said diaphragm, and

conduit means connected to said aperture means for conducting pumpingflow to said chamber,

said pumping chambers enabling central flow of blood in said blood flowchamber.

2. The ventricle of claim 1 wherein said pumping chambers are sodisposed that when fully expanded the flexible membranes do not toucheach other, thereby minimizing red cell trauma.

3. The ventricle of claim 1 wherein said pumping chambers are disposedto diverge from each other upwardly and outwardly from a lower end ofsaid shell means.

4. The ventricle of claim 1 wherein said shell means is made from stiffsilicone rubber.

5. The ventricle of claim 1 wherein said shell means is made from glassfiber cloth impregnated with epoxy resin.

6. The ventricle of claim 1 wherein said shell means is made from metal.

7. The ventricle of claim 1 wherein said bloodexposed surfaces are allcovered with Dacron velour.

8. The ventricle of claim 1 wherein said flexible membrane is offlexible silicone rubber.

9. The ventricle of claim 1 wherein said flexible membrane is ofelastomer-impregnated nonexpandable cloth.

10. The ventricle of claim 1 having valves in both said inlet and outletmeans.

11. The ventricle of claim 1 having an artificial atrium detachablyconnected to said inlet means.

12. The ventricle of claim 11 having an artificial sinus detachablyconnected to said outlet means.

13. The ventricle of claim 12 wherein both said detachable connectionscomprise a pair of rings, one rotatably mounted to said ventricle, theother being secured in one instance to said sinus and in the otherinstance to said atrium, each ring of each pair having a flange withsuture openings therethrough, the rotatable mounting of said one ring ofeach pair enabling alignment of its suture openings with those of theother ring of that pair.

14. The ventricle of claim 13 wherein a valve is seated by press fit inan annular shouldered recess in each said ring that is mounted to saidventricle.

15. An artificial heart assembly comprising in combination:

a. a pair of ventricles,

b. a pair of atria, one connected to each said ventricle,

c. a pair of sinus, one connected to each said ventricle,

d. means to provide pumping fluid to said assembly,

e. outflow means for pumped blood, including a valve for each ventricle,

f. intake means for blood to be pumped, including a valve for eachventricle,

g. each said ventricle comprising:

1. a rigid outer shell providing a ventricular cavity,

2. at least two pumping chambers disposed in said cavity and having oneflexible nonstretching diaphragm wall separating each said pumpingchamber from a blood-flow chamber in said cavity and a more rigid innershell sealed to each said diaphragm and secured to said outer shell,

3. said inner shell having an aperture therein to permit entry ofpumping fluid into said pumping chamber,

4. blood-compatible material covering all bloodexposed surfaces in saidcavity; and

5. means to conduct pumping fluid to said pumping chamber,

6. said chambers being of predetermined capacity.

16. The assembly of claim 15 wherein said bloodcompatible material isDacron velour.

17. The assembly of claim 15 wherein each said ventricle has twoconnectors, each having a body with an annular shouldered recess, and astiff radial flange rotatably mounted to said body and havingcircumferentially spaced holes therethrough, one said valve being seatedand held in each said recess, a connector for each atrium and each sinusmated with a connector on said ventricle and each having a radial flangewith circumferentially spaced holes therethrough and alignable withthose of a flange on the ventricles connector, by rotation of the flangeon the ventricles connector, for suturing said flanges together.

18. The assembly of claim 17 wherein each said valve is a low-profilevalve having an annular housing press fitted into said recess.

19. An artificial heart ventricle assembly comprising in combination:

a. a ventricle,

b. an atrium separate from said ventricle and separately attachable to apatient's atrial remnant before attachment to said ventricle,

c. an atrioventricular valve enclosed between said atrium and saidventricle upon attachment of said atrium to said ventricle,

d. a sinus separate from said .ventricle and separately attachable to apatient's aorta or pulmonary artery before attachment to said ventricle,

e. a sinuventricular valve enclosed between said sinus and saidventricle upon attachment of said sinus to said ventricle,

f. means for providing pumping fluid for said ventricle,

each said ventricle comprising:

1. a rigid shell providing a ventricular cavity,

2. at least two pumping chambers disposed in said cavity each having oneflexible nonstretching wall and one rigid wall sealed to each other,

3. each said rigid wall secured to said shell and having an aperture forentry of pumping fluid into said chamber,

4. each said flexible wall dividing said pumping chamber from ablood-flow chamber in said cavity,

5. blood-compatible material covering all bloodexposed surfaces in saidcavity; and

6. means for conducting said pumping fluid to said pumping chamber, 7.said chambers being of predetermined capacity.

20. The assembly of claim 19 wherein said bloodcompatible material isDacron velour.

21. The assembly of claim 19 wherein said atrium and said sinus eachhave a female connector having an annular socket receptacle and a radialflange having a plurality of spaced openings therethrough and saidventricle has two male connectors each pluggable into a said socketreceptacle and having a radial flange mounted rotatably to said maleconnector and having a plurality of spaced openings therethrough likethose of said flange of said female connector alignable therewith byrotation relative to said male connector, for suturing together of saidmating connectors.

22. The assembly of claim 21 wherein each said male connector has anannular shouldered recess, one receiving said atrioventricular valve andone receiving said sinuventricular valve for press fit therewith.

23. A heart assist device, comprising in combination a. an artificialventricle comprising 1. a rigid shell providing a ventricular cavity, 2.at least two pumping chambers disposed in said cavity, each having oneflexible nonstretching wall and one rigid wall sealed to each other,

3. each said rigid wall secured to said shell and having an aperture forentry of pumping fluid into said chamber,

4. said flexible wall dividing said pumping chamber from a blood-flowchamber in said cavity,

5. blood-compatible material covering all bloodexposed surfaces in saidcavity,

6. means for conducting said pumping fluid to each said pumping chamber,

7. inflow and outflow valves for blood flowing to and from saidblood-flow chamber,

b. an apex connector, covered with blood-compatible material, havingmeans enabling suture of said connector to a patients heart andproviding a channel for removal of blood from that heart, and

c. conduit means for connecting said apex connector to said artificialventricle and for connecting said ventricle to the patients descendingaorta.

24. The device of claim 23 wherein said conduit means comprises arterialgraft tubing.

25. The device of claim 23 wherein each said conduit means is connectedto said ventricle by a connector assembly comprising a male connectorand a female connector, each having a body and a radial flange withidentically spaced perforations therethrough, one said radial flangebeing rotatable relative to its said body.

26. The device of claim 23 wherein said apex connector comprises a rigidtube lined exteriorly and interiorly with blood compatible material andhaving a terminal radial flange for engaging the interior wall of thepatients heart, and a radial sewing flange spaced away from saidterminal flange and suturable to the heart muscles.

27. The device of claim 26 wherein said rigid tube has a radial flangeto which said sewing flange is sutured.

' UNITED STATES PATENT OFFlCE CERTIFICATE OF CORRECTION Patent No.3,766,567 Dated October 23, 1973 Inventor(s) Paul Kahn and Ronald C.Brown It is certified that error appears in the above-identified patentand that said Letters Patent are hereby corrected as shown below:

Item [56} References Cited, in the heading, rightrhand column, line 5,"Fn't-a. Organs should read --Int. Organs--.

Column 6, line 34, "venricle should read -ventricle v Column 6 line 66,"said verticle shell" should read --said ventricle shell".

Column 7, line ll, at the end of this paragraphfl'shell." should Signedand sealed this 6th day of August 1974.

(SEAL) .Attest:

MCCOY M. GIBSON, JR. c. MARSHALL DANN Attesting Officer Commissioner ofPatents

1. An improved artificial ventricle including in combination: agenerally rigid ventricle shell means providing a ventricular cavity andhaving inlet means and outlet means for blood, said verticle shell meanscomprising an outer shell and an inner shell, pumping means providing atleast two pumping chambers within said cavity and comprising a diaphragmfor each pumping chamber secured between said inner and outer shells anddividing the pumping chamber from a blood-flow chamber in said cavity,each said diaphragm being a flexible, non-stretching, imperviousmembrane, said inner shell having aperture means enabling entrance ofpumping fluid into said pumping chambers, said inner shell being sealedat its back side to each said diaphragm and to said outer shell,blood-compatible material covering all blood-exposed surfaces of saidventricle shell and said diaphragm, and conduit means connected to saidaperture means for conducting pumping flow to said chamber, said pumpingchambers enabling central flow of blood in said blood flow chamber. 2.The ventricle of claim 1 wherein said pumping chambers are so disposedthat when fully expanded the flexible membranes do not touch each other,thereby minimizing red cell trauma.
 2. at least two pumping chambersdisposed in said cavity and having one flexible nonstretching diaphragmwall separating each said pumping chamber from a blood-flow chamber insaid cavity and a more rigid inner shell sealed to each said diaphragmand secured to said outer shell,
 2. at least two pumping chambersdisposed in said cavity, each having one flexible nonstretching wall andone rigid wall sealed to each other,
 2. at least two pumping chambersdisposed in said cavity each having one flexible nonstretching wall andone rigid wall sealed to each other,
 3. each said rigid wall secured tosaid shell and having an aperture for entry of pumping fluid into saidchamber,
 3. each said rigid wall secured to said shell and having anaperture for entry of pumping fluid into said chamber,
 3. said innershell having an aperture therein to permit entry of pumping fluid intosaid pumping chamber,
 3. The ventricle of claim 1 wherein said pumpingchambers are disposed to diverge from each other upwardly and outwardlyfrom a lower end of said shell means.
 4. The ventricle of claim 1wherein said shell means is made from stiff silicone rubber. 4.blood-compatible material covering all blood-exposed surfaces in saidcavity; and
 4. said flexible wall dividing said pumping chamber from ablood-flow chamber in said cavity,
 4. each said flexible wall dividingsaid pumping chamber from a blood-flow chamber in said cavity, 5.blood-compatible material covering all blood-exposed surfaces in saidcavity,
 5. blood-compatible material covering all blood-exposed surfacesin said cavity; and
 5. means to conduct pumping fluid to said pumpingchamber,
 5. The ventricle of claim 1 wherein said shell means is madefrom glass fiber cloth impregnated with epoxy resin.
 6. The ventRicle ofclaim 1 wherein said shell means is made from metal.
 6. said chambersbeing of predetermined capacity.
 6. means for conducting said pumpingfluid to said pumping chamber,
 6. means for conducting said pumpingfluid to each said pumping chamber,
 7. inflow and outflow valves forblood flowing to and from said blood-flow chamber, b. an apex connector,covered with blood-compatible material, having means enabling suture ofsaid connector to a patient''s heart and providing a channel for removalof blood from that heart, and c. conduit means for connecting said apexconnector to said artificial ventricle and for connecting said ventricleto the patient''s descending aorta.
 7. said chambers being ofpredetermined capacity.
 7. The ventricle of claim 1 wherein saidblood-exposed surfaces are all covered with Dacron velour.
 8. Theventricle of claim 1 wherein said flexible membrane is of flexiblesilicone rubber.
 9. The ventricle of claim 1 wherein said flexiblemembrane is of elastomer-impregnated non-expandable cloth.
 10. Theventricle of claim 1 having valves in both said inlet and outlet means.11. The ventricle of claim 1 having an artificial atrium detachablyconnected to said inlet means.
 12. The ventricle of claim 11 having anartificial sinus detachably connected to said outlet means.
 13. Theventricle of claim 12 wherein both said detachable connections comprisea pair of rings, one rotatably mounted to said ventricle, the otherbeing secured in one instance to said sinus and in the other instance tosaid atrium, each ring of each pair having a flange with suture openingstherethrough, the rotatable mounting of said one ring of each pairenabling alignment of its suture openings with those of the other ringof that pair.
 14. The ventricle of claim 13 wherein a valve is seated bypress fit in an annular shouldered recess in each said ring that ismounted to said ventricle.
 15. An artificial heart assembly comprisingin combination: a. a pair of ventricles, b. a pair of atria, oneconnected to each said ventricle, c. a pair of sinus, one connected toeach said ventricle, d. means to provide pumping fluid to said assembly,e. outflow means for pumped blood, including a valve for each ventricle,f. intake means for blood to be pumped, including a valve for eachventricle, g. each said ventricle comprising:
 16. The assembly of claim15 wherein said blood-compatible material is Dacron velour.
 17. Theassembly of claim 15 wherein each said ventricle has two connectors,each having a body with an annular shouldered recess, and a stiff radialflange rotatably mounted to said body and having circumferentiallyspaced holes therethrough, one said valve being seated and held in eachsaid recess, a connector for each atrium and each sinus mated with aconnector on said ventricle and each having a radial flange withcircumferentially spaced holes therethrough and alignable with those ofa flange on the ventricle''s connector, by rotation of the flange on theventricle''s connector, for suturing said flanges together.
 18. Theassembly of claim 17 wherein each said valve is a low-profile valvehaving an annular housing press fitted into said recess.
 19. Anartificial heart ventricle assembly comprising in combination: a. aventricle, b. an atrium separate from said ventricle and separatelyattachable to a patient''s atrial remnant before attachment to saidventricle, c. an atrioventricular valve enclosed between said atrium andsaid ventricle upon attachment of said atrium to said ventricle, d. asinus separate from said ventricle and separately attachable to apatient''s aorta or pulmonary artery before attachment to saidventricle, e. a sinuventricular valve enclosed between said sinus andsaid ventricle upon attachment of said sinus to said ventricle, f. meansfor providing pumping fluid for said ventricle, each said ventrIclecomprising:
 20. The assembly of claim 19 wherein said blood-compatiblematerial is Dacron velour.
 21. The assembly of claim 19 wherein saidatrium and said sinus each have a female connector having an annularsocket receptacle and a radial flange having a plurality of spacedopenings therethrough and said ventricle has two male connectors eachpluggable into a said socket receptacle and having a radial flangemounted rotatably to said male connector and having a plurality ofspaced openings therethrough like those of said flange of said femaleconnector alignable therewith by rotation relative to said maleconnector, for suturing together of said mating connectors.
 22. Theassembly of claim 21 wherein each said male connector has an annularshouldered recess, one receiving said atrioventricular valve and onereceiving said sinuventricular valve for press fit therewith.
 23. Aheart assist device, comprising in combination a. an artificialventricle comprising
 24. The device of claim 23 wherein said conduitmeans comprises arterial graft tubing.
 25. The device of claim 23wherein each said conduit means is connected to said ventricle by aconnector assembly comprising a male connector and a female connector,each having a body and a radial flange with identically spacedperforations therethrough, one said radial flange being rotatablerelative to its said body.
 26. The device of claim 23 wherein said apexconnector comprises a rigid tube lined exteriorly and interiorly withblood compatible material and having a terminal radial flange forengaging the interior wall of the patient''s heart, and a radial sewingflange spaced away from said terminal flange and suturable to the heartmuscles.
 27. The device of claim 26 wherein said rigid tube has a radialflange to which said sewing flange is sutured.